News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Judicial Authority Statutory Interpretation

Venable LLP

Is Trouble Brewing for Dietary Ingredients? Court Upholds NYC Kava Ban

Venable LLP on

The U.S. District Court for the Southern District of New York recently upheld New York City's prohibition on steeped kava beverages, concluding that steeping kava root in water constitutes the creation of an unapproved "food...more

McCarter & English, LLP

Texas District Court Vacates FDA’s Final Rule Expanding Oversight to Laboratory Tests in Hospitals

In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...more

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

King & Spalding on

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

McDermott Will & Schulte

Loper Bright Could Shift Outlook for FDA Legal Challenges

The US Supreme Court has overruled the longstanding Chevron doctrine, an administrative law doctrine that required courts to defer to reasonable agency interpretations of ambiguous statutes. Loper Bright Enterprises v....more

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